(255 days)
Not Found
No
The device description and performance studies focus on the principle of protein electrophoresis and electrical cleaning, with no mention of AI or ML technologies.
No
A therapeutic device intends to treat or cure a disease or condition. This device is an adjunct cleaner for contact lenses and does not treat, cure, or prevent any disease or condition.
No
The device is an electrical cleaner for soft hydrophilic contact lenses, intended for deproteinization and storage. It is used to clean contact lenses, not to diagnose medical conditions.
No
The device description explicitly states it is an "electrical cleaner" and details physical components like a "cleaning unit (Power Base)", "partitioned fluid reservoir", "cleaning chamber", "cleaning tanks", "cleaning probe", "electrode", "circuit board", and "electrode connectors". This indicates a hardware-based device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to clean and deproteinize soft contact lenses. This is a process performed on a medical device (contact lenses) to maintain their function and hygiene, not to diagnose a condition or analyze a biological sample from a patient.
- Device Description: The device description details an electrical cleaner that uses protein electrophoresis to remove protein from contact lenses. This is a physical cleaning process, not a diagnostic test.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological samples from a patient.
- Performance Studies: The performance studies focus on the device's ability to remove protein from contact lenses and its physical compatibility with lenses. These are performance metrics related to the cleaning function, not diagnostic accuracy.
Therefore, the 3N Contact Lenses Adjunct Cleaner is a medical device intended for the care and maintenance of contact lenses, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
3N Contact Lenses Adjunct Cleaner is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses with only either OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution or Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution.
Product codes
LYL
Device Description
The proposed device, 3N Contact Lenses Adjunct Cleaner, Model TN083 is an electrical cleaner which is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses using approved contact lens solutions.
The 3N Contact Lenses Adjunct Cleaner adopt the principle of protein electrophoresis, take advantage of the characteristics that negatively charged protein in certain environment and swarm towards positive pole in electric field, then the tear protein will be removed from the surface and air holes of contact lens and absorbed by anodic cleaning probe to achieve the goal of cleaning contact lenses.
The cleaning components of the 3N Contact Lenses Adjunct Cleaner (Model: TN083) consist of a cleaning unit (Power Base) and a partitioned fluid reservoir functioning as the cleaning chamber.
The cleaning chamber is detachably connected to the cleaning unit (power base). In the cleaning chamber, there are two independent cleaning tanks; and there is a cleaning probe on each side of the cleaning tank, namely electrode. In the cleaning unit, the circuit board is fixedly provided with electrode connectors electrically connected to the circuit board. The end of the electrode connector can be stretched and elastically connected with the bottom of the electrode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following performance data were provided in support of the substantial equivalence determination:
7.1 Biocompatibility testing
The biocompatibility evaluation for the 3N Contact Lenses Adjunct Cleaner is conducted in accordance with the International Standard ISO10993-1 " Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The worst case of the device is considered mucosal membranes contacting for duration of less than 24 hours. And the testing included the following tests:
- Cytotoxicity Study using MTT Method
- Guinea Pig Maximization Test
- Ocular Irritation test
7.2 Software Verification and Validation
Software documentation, including verification, was provided following FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a minor level of concern.
7.3 Safety and EMC
Testing was performed to verify the basic safety and essential performance of the 3N Contact Lenses Adjunct Cleaner, TN 083. The following tests were performed: IEC 61010-1:2010+A1:2016 Safety requirements for electrical equipment for measurement, control, and laboratory use-Part1: General requirements IEC 61326-1:2013 Electrical equipment for measurement, control and laboratory use-EMC requirements- Part 1: General requirements
7.4 Performance Testing- Bench
The following tests were performed to demonstrate that the proposed 3N contact lenses adjunct cleaner met the applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO and other international standards.
Deproteinization efficiency testing and Service life testing
Testing was performed to verify the Protein removal effect of the 3N contact lenses adjunct cleaner. This verification test selected lenses of four kinds of materials from Johnson and Cooper Optics. After soaking in artificial tears, Ocufilcon D and Etafilcon A soft contact lenses had a large amount of protein adsorption. The protein cleaning rate was more than 92.5% with 3N contact lenses adjunct cleaner combined with care solution. However, Comfilcon A and Senofilcon A soft contact lenses have very little protein adsorption, so it is impossible to calculate the clearance effect. The protein removal rate of Ocufilcon D soft contact lens was 95% after 3N contact lenses adjunct cleaner was recycled for 0, 151 times. So the shelf life of the 3N contact lenses adjunct cleaner is 3 months.
Physical compatibility testing
The testing was considerably streamlined just assessing 3 low modulus high water SCLs (>50wt% water, for example 3 commercial lenses from any of these SCL materials, hioxifilcon A, nelfilcon A or nesofilcon A, or other high water materials) with the 3N device.
Deviation of the parameters of contact lenses before and requirements after cleaned by 3N Contact Lenses Adjunct Cleaner complies with the relevant requirements in ISO 18369-2:2017.
- Cleaning Validation was performed to demonstrate functionality is not affected after maximum number of cleaning cycles. The device was cleaned following the procedure defined in the User's Manual.
7.5 Performance Testing - Animal
This submission does not include any animal performance testing. It was determined that no such testing was required to demonstrate substantial equivalence.
7.6 Performance Testing - Clinical
This submission does not include any clinical performance testing. It was determined that no such testing was required to demonstrate substantial equivalence.
Key Metrics
Protein cleaning rate was more than 92.5% with 3N contact lenses adjunct cleaner combined with care solution.
The protein removal rate of Ocufilcon D soft contact lens was 95% after 3N contact lenses adjunct cleaner was recycled for 0, 151 times.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 13, 2022
Suzhou 3N Biological Technology Co., Ltd Wang Xiaofang Quality and Regulatory Division Manager NO.218 Xinghu Street Suzhou, Jiangsu 215000 China
Re: K211361
Trade/Device Name: 3N Contact Lenses Adjunct Cleaner Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LYL Dated: December 10, 2021 Received: December 10, 2021
Dear Wang Xiaofang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211361
Device Name 3N Contact Lenses Adjunct Cleaner
Indications for Use (Describe)
3N Contact Lenses Adjunct Cleaner is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses with only either OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution or Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image contains a logo with the number 3 in a stylized font, followed by the text "3N科技" and "3N TECH". The number 3 is designed with blue geometric shapes, and the text is in a simple, sans-serif font. The logo appears to represent a technology company named 3N Tech.
510(K) Summary
This 510(k) Summary is provided per the requirements of section 21 CFR 807.92.
The assigned 510(k) number is K211361.
Date Summary Prepared: 1/11/2022.
1. Submitter
| Submitter's Name: | Suzhou 3N Biological Technology Co., Ltd |
|---|---|
| Contact person: | Wang Xiaofang |
| Head of Quality and Regulatory | |
| Address: | NO.218, Xinghu Street, BioBay, SIP Suzhou, Jiangsu, PRC |
| China | |
| Telephone: | 0512-62757627/+8617317293095 |
| Email: | xiaofang.wang@3nbio.com |
2. Device
| Trade Name | 3N Contact Lenses Adjunct Cleaner |
|---|---|
| Common Name | Contact Lenses Adjunct Cleaner |
| Regulation Description | Contact lens care products |
| Regulation number | 21 CFR 886.5928 |
| Device Class | Class II |
| Product Code | LYL |
3. Predicate Device
RIM-WIDE COMPANIES, INC. LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY, K982115 (RIM-WIDE COMPANIES, INC.) FDA cleared on 01/13/1999.
4. Description of Proposed Device:
The proposed device, 3N Contact Lenses Adjunct Cleaner, Model TN083 is an electrical cleaner which is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses using approved contact lens solutions.
4
Image /page/4/Picture/0 description: The image shows the logo for 3N Tech. The logo consists of a stylized blue number 3 on the left, followed by the text "3N" in a simple sans-serif font. Below "3N" is the text "3N TECH" in a smaller font. The logo is clean and modern, with a focus on the number 3 and the company's name.
The 3N Contact Lenses Adjunct Cleaner adopt the principle of protein electrophoresis, take advantage of the characteristics that negatively charged protein in certain environment and swarm towards positive pole in electric field, then the tear protein will be removed from the surface and air holes of contact lens and absorbed by anodic cleaning probe to achieve the goal of cleaning contact lenses.
The cleaning components of the 3N Contact Lenses Adjunct Cleaner (Model: TN083) consist of a cleaning unit (Power Base) and a partitioned fluid reservoir functioning as the cleaning chamber.
The cleaning chamber is detachably connected to the cleaning unit (power base). In the cleaning chamber, there are two independent cleaning tanks; and there is a cleaning probe on each side of the cleaning tank, namely electrode. In the cleaning unit, the circuit board is fixedly provided with electrode connectors electrically connected to the circuit board. The end of the electrode connector can be stretched and elastically connected with the bottom of the electrode.
5. Indications for Use
3N Contact Lenses Adjunct Cleaner is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses with only either OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution or Bausch & Lomb ReNu Multi-Purpose Solution.
Comparison of Technological Characteristics with the Predicate Devices 6.
The following table compares the device to the predicate device with basic technological characteristics.
Both subject and predicate devices are electrical contact lens cleaning device and used in conjunction with approved contact lens solutions.
3N Contact Lenses Adjunct Cleaner, TN083 has been compared to LENSERVER Automatic Contact Lens Cleaning Accessory as a predicate device for substantial equivalence. A table comparing the two devices is provided as follows:
| Features | Proposed Device
(K211361) | Predicate Device
(K982115) | Comparison |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product code | LYL | LYL | Same |
| Regulation No. | 21 CFR 886.5928 | 21 CFR 886.5928 | Same |
| Device Class | Class II | Class II | Same |
| Indications for Use | 3N Contact Lenses Adjunct
Cleaner is intended for use as an | The LENSERVER Automatic
Contact Lens Cleaning Accessory | Similar
Note 1 |
| | adjunct in deproteinization and
storage for soft hydrophilic
contact lenses with only either
OPTI-FREE EXPRESS Multi-
Purpose Disinfecting Solution or
Bausch & Lomb ReNu MultiPlus
Multi-Purpose Solution. | is intended for use as an adjunct
in cleaning both soft hydrophilic
and rigid gas permeable contact
lenses using approved contact
lens cleaning solutions.
Examples of approved cleaning
solutions indicated for use with
the LENSERVER Automatic for
soft hydrophilic lenses are the
Allergan Soft Mate Consept-1
Cleaning and Disinfecting
Solution, Allergan Soft Mate
Cdrisept-2 Neutralizing and
Rinsing Solution, or Spray. The
LENSERVER Automatic is
indicated for cleaning rigid gas
permeable lenses in conjunction
with approved solutions such as
Allergan Gas Permeable Daily
Cleaner and Allergan
ComfortCare Gas Permeable
Wetting and Soaking Solution. | |
| Technical Principle | Protein electrophoresis | Ultrasonic Cleaning | Different
Note 2 |
| Mechanism of
Action | Electrical | Electro-mechanical | Different
Note 3 |
| Configuration | Cleaning Unit(Power Base)
Cleaning chamber | Motorized cleaning unit
Cleaning beaker | Similar
Note 4 |
| Shutdown mode | Automatic timing shutdown | Automatic timing shutdown | Same |
| Power | Built-in lithium battery | Dry Battery | Different
Note 5 |
| Material | Medical grade ABS | Medical grade
polymethylpentene | Similar
Note 6 |
| Sterile | Non-sterile | Non-sterile | Same |
| Single use | No | No | Same |
| Environment of
Use | home | home | Same |
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Image /page/5/Picture/1 description: The image contains a logo for 3N Tech. The logo consists of a blue stylized number 3 on the left, followed by the text "3N 科技" in Chinese characters and "3N TECH" in English. The number 3 is made up of three connected lines, with a small square above the top line.
The following technological differences exist between the subject and predicate devices:
Note 1
6
Image /page/6/Picture/0 description: The image contains a logo with the number 3 in a stylized font, along with the text "3N科技" and "3N TECH". The number 3 is in blue and is made up of two parts, a darker blue and a lighter blue. The text "3N科技" is in black and is written in a Chinese font. The text "3N TECH" is in black and is written in a sans-serif font.
The intended use of proposed device and predicate device are similar. The proposed device has storage function. It is expected that the proposed device has more storage functions than the predicate device, just like a contact lens case.
It will not affect the main function and intended use of the device, and indications for use of proposed device is clearly indicated in user manual and label. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.
Note 2 and Note 4
The technical principle and configuration of proposed device and predicate device are different, but it will not affect the main function and the intended use of the device. They are both electrical means. And they are both compliance with electrical safety Standard. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.
Note 3
The mechanism of action of proposed device and predicate device are different, but it will not affect the main function and the intended use of the device. They are both meet the related standards and requirements of physical compatibility. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.
Note 5
The battery type of proposed device and predicate device are different. They are both compliance with electrical safety standard, it will not raise any safety or effectiveness issue.
Note 6
The main materials of the proposed device and predicate device are different. They are both compliance with medical requirements and standard ISO 10993-1, 10993-11. It will not raise any safety or effectiveness issue.
7. Non-Clinical Data
The following performance data were provided in support of the substantial equivalence determination.
7.1 Biocompatibility testing
The biocompatibility evaluation for the 3N Contact Lenses Adjunct Cleaner is conducted in accordance with the International Standard ISO10993-1 " Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The worst case of the device is considered mucosal membranes contacting for duration of less than 24 hours. And the testing included the following tests:
7
Image /page/7/Picture/0 description: The image contains the logo for 3N Tech. The logo consists of a stylized number 3 in blue, with a small square in the upper right corner. To the right of the number 3 is the text "3N科技" in Chinese characters, followed by the text "3N TECH" in English.
- Cytotoxicity Study using MTT Method
- Guinea Pig Maximization Test
- Ocular Irritation test
7.2 Software Verification and Validation
Software documentation, including verification, was provided following FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a minor level of concern.
7.3 Safety and EMC
Testing was performed to verify the basic safety and essential performance of the 3N Contact Lenses Adjunct Cleaner, TN 083. The following tests were performed: IEC 61010-1:2010+A1:2016 Safety requirements for electrical equipment for measurement, control, and laboratory use-Part1: General requirements IEC 61326-1:2013 Electrical equipment for measurement, control and laboratory use-EMC
requirements- Part 1: General requirements
7.4 Performance Testing- Bench
The following tests were performed to demonstrate that the proposed 3N contact lenses adjunct cleaner met the applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO and other international standards.
● Deproteinization efficiency testing and Service life testing
Testing was performed to verify the Protein removal effect of the 3N contact lenses adjunct cleaner. This verification test selected lenses of four kinds of materials from Johnson and Cooper Optics. After soaking in artificial tears, Ocufilcon D and Etafilcon A soft contact lenses had a large amount of protein adsorption. The protein cleaning rate was more than 92.5% with 3N contact lenses adjunct cleaner combined with care solution. However, Comfilcon A and Senofilcon A soft contact lenses have very little protein adsorption, so it is impossible to calculate the clearance effect. The protein removal rate of Ocufilcon D soft contact lens was 95% after 3N contact lenses adjunct cleaner was recycled for 0, 151 times. So the shelf life of the 3N contact lenses adjunct cleaner is 3 months.
● Physical compatibility testing
The testing was considerably streamlined just assessing 3 low modulus high water SCLs (>50wt% water, for example 3 commercial lenses from any of these SCL materials, hioxifilcon A, nelfilcon A or nesofilcon A, or other high water materials) with the 3N device.
Deviation of the parameters of contact lenses before and requirements after cleaned by 3N Contact
8
Image /page/8/Picture/0 description: The image contains a logo with the number 3 on the left side, and the text "3N科技" and "3N TECH" on the right side. The number 3 is stylized with a blue color scheme. The text "3N科技" is in Chinese characters, and the text "3N TECH" is in English. The logo is likely for a technology company.
Lenses Adjunct Cleaner complies with the relevant requirements in ISO 18369-2:2017.
- Cleaning Validation was performed to demonstrate functionality is not affected after maximum number of cleaning cycles. The device was cleaned following the procedure defined in the User's Manual.
7.5 Performance Testing - Animal
This submission does not include any animal performance testing. It was determined that no such testing was required to demonstrate substantial equivalence.
7.6 Performance Testing - Clinical
This submission does not include any clinical performance testing. It was determined that no such testing was required to demonstrate substantial equivalence.
8. Conclusion
From the bench test conducted on the proposed device provided in above, the test result showed that the proposed device can meet the requirements of related standards. Therefore, it can be determined that the proposed devices are Substantially Equivalent (SE) to the predicate device, K982115.